Wound site management and wound closure device

ABSTRACT

A staple, a stapler, and an introducer are disclosed for closing a wound and for wound site management. The staple is deformable, and includes a plurality of tissue-piercing prongs which are expanded outwardly, inserted into tissue and collapsed inwardly to close the wound. The stapler includes a plurality of mechanisms to deform the staple into various positions. An introducer is provided that includes a plurality of spaced-apart wire guides for securing and centering the wound opening during a medical procedure, and during closure of the wound.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10/338,466 filed on Jan. 8, 2003, which is a continuation of U.S. patentapplication Ser. No. 09/658,787, filed on Sep. 11, 2000, now U.S. Pat.No. 6,506,210, which claims the benefit of U.S. provisional patentapplication Ser. No. 60/230,234, filed on Sep. 1, 2000.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a wound site management and woundclosure device and method, for use during and after a medical procedure.More specifically, the present invention relates to a staple andstapling device for closing a puncture made in the wall of an artery orvein during a medical procedure. The puncture may be the result of acatheter-based intervention, although any puncture is contemplated,accidental or intentional. The present invention has particular utilityfor use in and around the femoral, radial, and brachial arteries aftercoronary/cardiac procedures. Other utilities include soft-tissueanchoring, tendon and artery joining, meniscal repair, thoracic lungclosure, heart repair, endoscopic procedures, esophageal repair,laparoscopy, skin/epidermal wound closure and general tissue closure.

2. Description of Related Art

Catheters/catheterization procedures are well known, and typicallyinvolve insertions through the femoral artery for diagnosis or to treatcardiovascular and/or peripheral vascular diseases. After a diagnosticor interventional catheterization, the puncture formed by the cathetermust be closed. The puncture opening in the artery typically ranges from5 F for a diagnostic procedure to 6-10 F for an interventionalprocedure. Traditionally, intense pressure has been applied to thepuncture site for at least 30-45 minutes after removal of the catheter.Other approaches include a thrombotic or collagen plug, and/or othersuturing methodology for sealing the puncture. Patients who have had afemoral puncture are then required to remain at bed rest, essentiallymotionless and often with a heavy sandbag placed on their upper legs,for several hours to ensure that the bleeding has stopped. Thistraditional method of hemostasis following femoral artery access hasmany inadequacies. When a blockage is removed during a procedure, thepatient quickly feels better and they often have more energy than theyhave had in years, but they must remain motionless for several hours.The weight of the sandbag on the femoral artery often causes the lowerleg to tingle or go numb. The recovery time from the medical proceduremay be as little as ½ hour, but the recovery time from the wound canexceed 24 hours. This makes wound site management the longer criticalcare item. The longer the recovery time, the more expensive theprocedure becomes, the greater the patient discomfort, and the greaterthe risk of complications.

Surgical stapling instruments have been proposed to resolve some of theaforementioned problems associated with vascular procedures. U.S. Pat.No. 5,709,335 issued to Heck discloses a wholly distal surgical staplinginstrument for stapling a tubular tissue structure to a luminalstructure, such as a vascular lumen. This device can be used foranastomotic stapling of a tubular vessel having two untethered ends, andis especially useful for making the primary anastomotic connection of abypass vein to a coronary artery or to the aorta. The device essentiallyincludes a rod that is placed within the tubular vessel and an anvilthat forces staples (associated with the rod) to bend outwardly againstthe vessel and a target (such as a coronary artery). Thus, this devicerequires that the stapler device be placed within the tubular vessel(e.g., vein or artery) for operation. While this device is useful whenstapling a graft vein or the like, unfortunately, this device would beinappropriate when the entirety of the tubular tissue is not accessible,such as wound closure following a percutaneous transluminal diagnosticand interventional procedures and less invasive medical procedures.

Another example is found in U.S. Pat. No. 5,695,504 issued to Gifford,III et al., discloses an end-to-side vascular anastomosis device toperform end-to-side anastomosis between a graft vessel and the wall of atarget vessel. This device involves a procedure in which the end of agraft vessel is passed through an inner sleeve of the device until theend of the vessel extends from the distal end of the device. The distalend of the graft is then affixed to the wall of the target, using astaple and stapler which forces a staple into both tissues. Similar tothe previous disclosures, this device is useful for the attachment ofone tubular tissue onto another, however, is inadequate in sealing apuncture in an artery, vein or other tissue left by certain medicalprocedures.

Moreover, the prior art has failed to provide a device that permits adoctor or clinician to gain access to a puncture site and remaincentered on that site throughout the entire procedure, including closureof the puncture. Additionally, prior art devices do not permit a doctoror clinician to directly or indirectly view the wound site, for examplethrough an endoscope, and thus success of the procedure at the site maybe compromised.

SUMMARY OF THE INVENTION

Accordingly, it is an overall object of the present invention to providea device and method for wound site management and closure during andafter medical procedures.

In one aspect, the present invention provides a tissue staple comprisinga plurality of prongs connected to a plurality of tabs and arrangedabout a centerline axis. The prongs have a shoulder portion extendingsubstantially orthogonal from the prong toward the centerline axis. Eachprong has a tapered tissue-piercing portion on the distal end thereof.

Alternatively, the staple of the present invention comprises a pluralityof prongs arranged about a centerline axis, each prong having a shoulderportion extending substantially orthogonal from the prong toward saidcenterline axis, and a plurality of web portions connecting each prongto one another, each prong having a tapered tissue-piercing portion onthe distal end thereof.

In another aspect, the present invention provides a stapler thatincludes an elongated sleeve having an inside diameter, an elongated rodwith a flared mandrel coupled to a distal end, the rod and mandrel sizedto fit within the inside diameter of the tube, an actuator mechanism tomove the rod relative to the sleeve, a staple adapted to fit betweensaid mandrel and said sleeve, and, said actuator mechanism adapted tomove said mandrel relative to said staple and said sleeve causing saidstaple to close on tissue located about a wound site.

Broader aspects of the stapler include a distal tip comprising a sleeveand a rod inserted into said sleeve, said rod comprising a flared distaltip; an actuator coupled to said sleeve and said rod, said actuatoradapted to cause said sleeve to move relative to said rod; and a tissuestaple comprising a plurality of tissue piercing prongs placed aroundsaid rod between said sleeve and said flared distal tip.

Wound closure procedures according to the present invention include aprocess for closing a wound comprising the steps of: inserting anintroducer into a tissue wound, placing a sheath around the introducerand locating the sheath approximate to said wound, inserting the distalend of a stapler into said sheath to approach the tissue wound site,said stapler including a tissue staple on the distal end of saidstapler, expanding a portion of the staple about said wound, andcontracting at least a portion of said staple pulling together thetissue surrounding the wound. Other wound closing methods include aprocess for closing a wound in an artery with a staple, comprising thesteps of: inserting an introducer with a plurality of guide wirescoupled thereto into an artery, guiding a stapler and staple to thewound site, expanding said staple to surround said wound site beforeentering said tissue, and closing said staple on said tissue to closesaid wound.

In yet another aspect, the present invention provides an introducer thatincludes a sheath having an inside diameter and a distal end, a dilatorsized to fit within the inside diameter of the sheath, and a pluralityof wire guides having first ends and second ends, the first ends coupledto the distal end of the sheath, wherein the sheath being approximatedto a wound site and the wire guides placed into the wound site to holdsaid sheath approximately centered on said wound site.

In broader embodiment, the introducer of the present invention includesa tubular sheath, and at least one flexible wire guide affixed to thesheath, said wire guide placed into a wound site to hold said sheathapproximately centered on said wound site.

In method form, the present invention also includes wound sitestabilization methodology including the steps of: approximating anelongated sheath to a wound site; inserting one or more wire guides intothe wound site; placing said wire guides approximate to tissuesurrounding said wound site; and allowing opposing sides of said tissuesurrounding said wound site to approximate one another.

Other procedural embodiments include a method for stabilizing a woundsite, comprising the steps of: approximating an elongated sheath to awound site; inserting one or more wire guides into the wound site;placing said wire guides approximate to tissue surrounding said woundsite; and centering said sheath about said wound site.

It will be appreciated by those skilled in the art that although thefollowing Detailed Description will proceed with reference being made topreferred embodiments, the present invention is not intended to belimited to these preferred embodiments. Other features and advantages ofthe present invention will become apparent as the following DetailedDescription proceeds, and upon reference to the Drawings, wherein likenumerals depict like parts, and wherein:

BRIEF DESCRIPTION OF THE DRAWINGS

It will be appreciated by those skilled in the art that although thefollowing Detailed Description will proceed with reference being madepreferred embodiments the present invention is not intended to belimited to these preferred embodiments. Other features and advantages ofthe present invention will become apparent as the following DetailedDescription proceeds, and upon reference to the Drawings, wherein likenumerals depict like parts, and wherein:

FIGS. 1-3 are isometric views of one embodiment of the staple of thepresent invention in formed, opened and deployed positions,respectively;

FIG. 3A depicts an isometric view of alternative staple of theembodiment of FIGS. 1-3;

FIGS. 4-6 are isometric views of another embodiment of the staple of thepresent invention in formed, opened and deployed positions,respectively;

FIG. 7 depicts one embodiment of the stapler of the present invention;

FIG. 8 is an isometric view of the distal tip of the stapler of FIG. 7adapted to hold and deploy the staple of FIGS. 1-6;

FIGS. 9A-11B are isometric views of the cooperative movement of thedistal tip of the stapler and the staple of the present invention;

FIGS. 12-15 are isometric views of an exemplary staple deploymentmechanism of the stapler of the present invention;

FIGS. 16 and 17 are isometric views of another exemplary stapledeployment mechanism of the stapler of the present invention; and

FIGS. 18-26 depict various views of procedural embodiments of thepresent invention, including FIG. 20 depicting one embodiment of theintroducer of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Tissue Staple

In one aspect of the present invention, a staple is provided to close atissue wound after a medical procedure. Although the preferred use ofthe staple of the present invention is to close an artery or veinfollowing a diagnostic or interventional procedure, it should berecognized at the outset that the staple may be used for general tissuerepair, not just limited to vascular repair. It will be appreciatedthroughout the following description that the staple of the presentinvention can be formed of any biocompatible and/or bioabsorbablematerials, including, for example, Titanium (and Titanium alloys),stainless steel, polymeric materials (synthetic and/or natural),ceramic, etc. It will also be apparent from the following descriptionthat the staple of the present invention is preferably formed of adeformable material (such as those listed above) that undergoes plasticdeformation (i.e., deformation with negligible elastic component.) As ageneral overview, the staple of the present invention undergoes twopositions of deformation: a first position to extend the distal ends ofthe prongs of the staple outwardly to grab a greater amount of tissue(and also to grab tissue away from the wound locus), and a secondposition to move the prongs inwardly to close the wound.

FIGS. 1, 2 and 3 depict one embodiment of staple 10 of the presentinvention. FIG. 1 is the staple in it's formed position, FIG. 2 is thestaple just prior to deployment into tissue with the prongs extendedoutwardly, and FIG. 3 is the staple closed around tissue. The staple 10of this embodiment comprises a plurality of prongs 12A-12D and aplurality of tabs 14A-14D, arranged about a centerline axis 100. Commonportions, or shoulders 16A-16D are formed where the tabs meet theprongs. Each shoulder is common to both the prong and the tab and isgenerally defined by a relatively flat portion generally orthogonal tothe centerline axis. Shoulders 16A-16D may be viewed as an extension ofeach prong, bent inwardly toward the centerline axis. Each of thesefeatures of the staple 10 of this embodiment is detailed below. In theformed position (FIG. 1), prongs 12A-12D extend generally parallel tocentral axis 100, as shown. At the distal end of each prong, taperedpoints 18A-18D is formed to extend inwardly toward the centerline axis100. At the proximal end, shoulders 16A-16D meet at prongs 12A-12D,respectively. Tabs 14A-14D are generally U-shaped, and are formedbetween each prong. The proximal portions of each tab are joined atconsecutive shoulders, as shown. Each proximal portion of the U (i.e.,each “leg” of the U-shape tab) extends first generally outward from theshoulder, and second bends inwardly and distally toward centerline axis100, connecting together nearest the centerline axis to form the Ushape. The U-shape defines slots 20A-20D within each tab having a basepositioned at the bottom thereof.

Referring specifically to FIG. 2, the staple 10 is deformed so thatprongs 12A-12D extend outwardly from the centerline axis, prior todeployment into tissue. It is advantageous to extend the prongsoutwardly as shown so as to grasp a large portion of tissue, and so thatinsertion of the prongs into the tissue occurs at a locus away from thewound site, thereby providing a more consistent wound closure (byclosing the wound with more of the surrounding tissue) and ensuringcomplete (or near complete) closure of the wound. To deform the stapleinto the position shown in FIG. 2, a force F₁ is applied to tabs14A-14D, as shown in relief in FIG. 2A. Force F₁ is generally outward(from the centerline axis) and proximal to the top of the staple, asshown in relief in FIG. 2A. This force causes the tabs to move outwardfrom the centerline axis 100. The outward movement of the tabs causesthe shoulder portions to pivot roughly about the juncture between theshoulder and the prong (i.e., at the outer portion of the shoulder),causing the inner portions of the shoulders to move inwardly toward thecenterline axis and distally. Since the prongs are attached to the outerportion of the shoulders, the movement of the shoulders in this mannercauses the prongs to move outwardly. Thus, the cross-sectional diameterof the staple gets larger at the distal end (with respect to thecross-sectional diameter of the formed staple of FIG. 1). Note that themovement of the prongs is generally greater at the distal portionsthereof than at the proximal portions thereof. In other words, movementof the prongs as shown in FIG. 2 is pivoted from the shoulder, thusproducing a staple with outwardly extending prongs. For completeness, itshould be noted that a holding force may be applied downwardly (i.e.,substantially parallel to the centerline axis) against the base of theslots 20A-20D to hold the staple in place. Also, it is preferred thatthese forces are simultaneously applied to each tab of the staple toproduce uniform deformation of each prong of the staple. As mentionedabove, it is preferable that the plastic deformation of the staple issemi-permanent, so that the staple does not tend to return to the shapedepicted in FIG. 1 (i.e., non-elastic deformation). Deformation of thestaple into this position will be described in greater detail below inreference to the preferred stapler device of the present invention.

FIG. 3 depicts the staple 10 in a closed position. The closed position,as stated herein generally means that the prongs of the staple are movedinwardly toward each other. Although FIG. 3 depicts the tapered tipportions of the prongs meeting generally in the vicinity of thecenterline axis, however, it should be understood that the term “closed”or “deployed” as used in reference to the staple need not necessarilymean this precise configuration. It may be required (or desirable) forsome procedures to move the prongs inwardly toward each other to agreater or lesser extent than as depicted in FIG. 3. To draw the stapleinto the closed position depicted in this Figure, a force F₃ is appliedto the inner surfaces 30A-30D of the shoulders. This force is generallyorthogonal to the centerline axis, and the angle between each forceapproximates the angle between the inner surfaces 30A-30D (which, in thestaple of this embodiment is approximately 90 degrees). This forcecauses the slots 20A-20D to spread apart and urges the shouldersoutwardly. Movement in this manner also causes the shoulders to moveoutwardly and proximally. Proximal movement of the shoulders causes theprongs to move toward each other. Opposite to the movement of FIG. 2,deformation shown in FIG. 3 results in an expanded cross-sectionaldiameter of the proximal end of staple, and a diminished cross-sectionaldiameter of the distal end of the staple (with respect to the formedstaple of FIG. 1 and the deformed staple of FIG. 2). Again, deformationof the staple 10 into this position will be described in greater detailbelow in reference to the preferred stapler device of the presentinvention.

For certain tissue application, it may be desirable that the staple ofthe present invention is deployed into tissue such that the prongs donot fully pierce through the tissue, but rather grasp and hold thetissue together. For example, for vascular closure applications it maybe desirable that the tissue piercing tapered ends not enter thebloodstream, but rather pierce into the tissue and stop short ofpiercing through the tissue wall. To that end, and referring to FIG. 3A,the staple 10′ of the present invention can be adapted with tissue stops32A-32D. Preferably, tissue stops 32A-32D are located along the lengthof each prong, and positioned from the distal tip of the prong to permitthe tapered ends to pierce tissue, but not pierce all the way throughthe tissue. Accordingly, the position of the stops 32A-32D along thelength of the prongs is selected to facilitate tissue grabbing (but notcomplete tissue piercing) and can vary from application to application.

FIGS. 4-6 depict another embodiment of a staple 50 of the presentinvention. FIG. 4 is the staple in it's formed position, FIG. 5 is thestaple just prior to deployment into tissue with the prongs extendedoutwardly, and FIG. 6 is the staple closed around tissue. Similar to thefirst embodiment, the staple 50 of this embodiment comprises a pluralityof prongs 52A-52D arranged about a centerline axis 100. A shoulder56A-56D is provided and is generally defined by a relatively flatsurface, generally orthogonal to centerline axis. Shoulders 56A-56D maybe viewed as an extension of each prong, bent inwardly toward thecenterline axis. In this embodiment, webs 54A-54D are connected to andbetween each prong, and are formed to extend inwardly from each prongtoward the centerline axis, creating a U shape generally orthogonal tothe centerline axis (as opposed to the previous embodiment in which theU-shaped tab is positioned generally parallel to the centerline axis).Each of the features of the staple 50 of this embodiment is detailedbelow.

In the formed position (FIG. 4), prongs 52A-52D extend generallyparallel to central axis 100, as shown. At the distal end of each prong,tapered points 58A-58D are formed to extend inwardly toward thecenterline axis 100. At the proximal end, shoulders 56A-56D meet atprongs 52A-52D, respectively. Web portions (webs) 54A-54D are generallyU-shaped, and are formed between each prong extending inwardly towardthe centerline axis. As shown, webs connect the prongs at a positiondistal to the shoulders. The precise position of the webs is determinedby the desired extent to which the prongs are extended outwardly, andthe extent to which the web curves inward toward the centerline axis.The space between the shoulders and the web portions defines a slot60A-60D.

Referring specifically to FIG. 5, the staple 50 is deformed so thatprongs 52A-52D extend outwardly from the centerline axis, prior todeployment into tissue. As with the previous embodiment, it isadvantageous to extend the prongs outwardly as shown so as to grasp alarge portion of tissue, and so that insertion of the prongs into thetissue occurs at a locus away from the wound site, thereby providing amore consistent wound closure (by closing the wound with more of thesurrounding tissue) and ensuring complete (or near complete) closure ofthe wound. To deform the staple into the position shown in FIG. 5, aforce F₁ is applied to webs 54A-54D, as shown in relief in FIG. 5A.Force F₁ is generally outward from the centerline axis and causes thewebs to deform outwardly, i.e., straightening the bend of the web bymoving the centermost point of the web outwardly. By deformation of theweb portions in this manner, the prongs move outwardly. Thus, thecross-sectional diameter of the staple gets larger at the distal end(with respect to the cross-sectional diameter of the formed staple ofFIG. 4). Note that the movement of the prongs is generally greater atthe distal portions thereof than at the proximal portions thereof, thusproducing a staple with outwardly extending prongs. For completeness, itshould be noted that a holding force may be applied downwardly (i.e.,substantially parallel to the centerline axis) against the top of thewebs in slots 60A-60D to hold the staple in place. Also, it is preferredthat these forces are simultaneously applied to each web of the stapleto produce uniform deformation of each prong of the staple. As mentionedabove, it is preferable that the deformation of the staple is plastic,so that the staple does not tend to return to the shape depicted in FIG.4. Deformation of the staple into this position will be described ingreater detail below in reference to the preferred stapler device of thepresent invention.

FIG. 6 depicts the staple 50 in a closed or deployed position. Theclosed position, as stated herein generally means that the prongs of thestaple are moved inwardly toward each other. To draw the staple into theclosed position depicted in this Figure, a force F₃ is applied to theinner surfaces 62A-62D of the shoulders. This force is generallyorthogonal to the centerline axis, and the angle between each forceapproximates the angle between the inner surfaces 62A-62D about thecenterline axis (which, in the staple of this embodiment isapproximately 90 degrees). This force urges the shoulders outwardly.Note that shoulders can only extend outwardly as far as the web portionswill permit. Outward movement of the shoulders causes the prongs to movetoward each other, since, there is a general pivot about the webportions. Opposite to the movement of FIG. 5, deformation shown in FIG.6 results in an expanded cross-sectional diameter of the proximal end ofstaple, and a diminished cross-sectional diameter of the distal end ofthe staple (with respect to the formed staple of FIG. 4 and the deformedstaple of FIG. 5). Again, deformation of the staple 50 into thisposition will be described in greater detail below in reference to thepreferred stapler device of the present invention.

In either embodiment described above, it should be evident that althoughthe Figures depict four each of the prongs, tabs and shoulders, thisshould be only be considered exemplary. It may be desirable to adapt thestaple 10 or the staple 50 with more or fewer prongs, tabs and shouldersfor a given application. Also, it is not necessary that each prong isthe same length, or that each prong has the same overall dimensions. Inalternative embodiments, the entire staple, or selected portions thereofcan be alternatively fashioned from an elastic or shape memory (e.g.,nitinol, and/or other elastic materials, including for exampletemperature dependant shape memory materials) material therebypermitting elastic deformation from the a static closed position to anexpanded position and then elastically close about the wound. Also, theembodiment of FIGS. 4-6 can be adapted with a tissue stop positionedalong the length of the prong, as shown in FIG. 3A.

Stapler Device

Another aspect of the present invention is a stapler device to deploythe staple 10 of FIGS. 1-3, the staple 10′ of FIG. 3A, and the staple 50of FIGS. 4-6. As a general overview, the stapler of the presentinvention includes a distal tip for holding and deploying a staple, andan actuator mechanism to cause a staple, or at least the tissue piercingportions of a staple, to expand outwardly and then close about a wound.The stapler of the present invention facilitates one object of thepresent invention to ensure that the staple closes a greater amount oftissue as compared with conventional stapling mechanisms. The followingdescription will detail various exemplary mechanisms to accomplish thisgoal, but it should be recognized that numerous alternatives will bereadily apparent to those skilled in the art, and all such alternativesare to accomplish these objectives are deemed within the scope of thepresent invention.

FIG. 7 depicts an isometric view of one embodiment of a stapling device100 of the present invention. The device generally includes an actuationmechanism 104 and a distal tip 102. FIG. 8 is a more detailed view ofthe distal tip 102 of the stapler device 200. The distal tip preferablycomprises an inner rod member 110 slidable within an outer sleeve 112.Rod 110 includes a flared or mandrel portion 114. Mandrel 114 alsoincludes slots 118A-118D, which in use are aligned with fingers116A-116D. Fingers 116A-116D mate with slots 20A-20D and 60A-60D of thestaple 10 and 50, respectively. Preferably, rod 110 is removable forstaple attachment thereto, where a staple is positioned between themandrel and the sleeve. The mandrel, as will be described below, isresponsible for the forces generated on the staple.

FIGS. 9, 10A, 10B, 11A and 11B depict the working relationship betweenthe staple 10′ and/or 50 of the present invention and the mandrel114/sleeve 112 of the stapler mechanism 200. In FIG. 9A, the staple 10′is placed between the mandrel 114 and sleeve 112. Slots 20A-20D of thestaple engage fingers 116A-116D of the sleeve. The prongs 12A-12D of thestaple are dimensioned so as to fit over the mandrel, and tabs 14A-14Dare dimensioned so as to fit over the rod 110, as shown. Similarly, forthe staple 50 shown in FIG. 9B the staple 50 engages the mandrel 114 andsleeve 112 (not shown). This is a static position, as no forces areapplied to the staple to cause deformation. In FIG. 10A, the staple 10′is urged into the first deformed position (of FIG. 2) by the relativemovement of the rod/mandrel and the sleeve. As shown, the mandrel isurged proximally. As the mandrel moves, the tabs of the staple meet thenarrowest part of the mandrel. Further movement forces the tabs to moveoutwardly, causing the prongs to likewise move outwardly (as describedabove with reference to FIG. 2). Once the tabs clear the mandrel,outward movement of the tabs and prongs ceases. Similarly, in FIG. 10B,the movement of the mandrel forces webs to extend outwardly causing theprongs to extend outwardly (as described above with reference to FIG.5). Once the webs clear the mandrel, outward movement of the prongsceases. FIG. 11A depicts final deployment of the staple into tissue. Asthe mandrel is drawn further proximally and once the tabs have clearedthe mandrel, the shoulders (not shown) are spread outward, forcing theprongs to move together (toward the centerline axis) and closing tissuetherebetween. FIG. 11B depicts the same actuation, but for the staple 50of FIGS. 4-6.

FIGS. 12-15 depict an exemplary actuator mechanism 104, showing therelative motion of the sleeve 112 and the mandrel rod 110. The mechanismincludes a cam 408 movable in a linear motion along a slot 412. Movementof the cam can be manual or through an electronically controllable motor(not shown). The cam 408 has lobes 408A and 408C located on a first sideof the cam 408 and a lobe 408B located on a second and opposing side ofthe cam 408. A first cam follower 418 is coupled to the mandrel rod 110,and is selectably engagable with lobes 408A and 408C. A second camfollower 416 is coupled to the sleeve 112, and is selectably engagablewith lobe 408B. FIG. 12 depicts that neither cam follower is in contactwith the lobes, and is indicative of an initial position of themechanism.

FIG. 13 depicts the mechanism 104 in a position to expand the staplebetween the mandrel 114 and the sleeve 112, as shown in FIG. 9A. As cam408 is moved (as indicated by the arrow), lobe 408A urges cam follower418 along slot 426. The mandrel rod 110 is moved proximally, causing theprongs to extend outwardly (as shown in FIGS. 2 and 5) as a result ofthe force of the mandrel 114 on the tabs or the web portions. Withfurther movement of the cam 408 (FIG. 14), lobe 408B now urges camfollower 416 to move distally, thereby moving the sleeve distallyrelative to the mandrel rod and causing further expansion of the prongsand causing the staple to move distally. Finally, in FIG. 15, the cam isurged yet further and cam follower 418 is urged by lobe 408C causing themandrel and madrel rod to extend further proximally. This relativemovement between the cam rod and the sleeve causes the mandrel to applya force to the shoulder portions of the staple, in turn causing inwardmovement of the prongs. Lobe 408C causes closure of the prongs anddecouples the staple from the mandrel. This is the fully deployed staplemovement.

FIGS. 16 and 17 show an alternative cam mechanism. Similar to theprevious example, cam 608 is urged in a direction indicated by the arrowto cause relative motion between the mandrel rod and the sleeve. Lobes608A and 608B are located on opposite sides of cam 608. As the cam 608is moved along slot 612, the lobe 608A urges a cam follower 618 in alinear motion along a slot 626. This urges the cam follower 618proximally. The cam follower 618 is coupled to a mandrel rod 604. Thisdeforms staple 10/50 in the second configuration (see FIG. 2 or 5). Asthe cam 608 is urged further, the cam follower 618 moves distally tostay in contact with the lobe 608A. This urges mandrel rod 604 distally.The same movement of the cam 608 urges lobe 608B to urge cam follower616 distally. The cam follower 616 is coupled to a sleeve 606. Thisurges sleeve 606 distally. The downward slope of lobe 608A is parallelwith upward slope of lobe 608B so the mandrel rod 604 and the sleeve 606move distally in unison and the staple is advanced into the tissue. Themovement of the cam follower 618 down the slope of lobe 608A then ceaseswhile the movement of cam follower 616 continues up the slope of lobe608B and the staple 10/50 is deformed into the closed or deployedconfiguration (see FIG. 3 or 6). Springs 614 and 650 can be provided toreturn cam followers 616 and 618, respectively, to an initial position.Of course an additional spring can be provided in slot 612 to move cam608 back to an original position.

Alternatively, the actuation mechanism can include a rotating drum (notshown) to replace the cam 408 and 612. The drum may be adapted withlobes formed thereon, similar to lobes 408A-408C and 608A-608B,respectively. Other alternatives may include a rotating screw having avariable width in accordance with lobes 408A-408C or 608A-608B toactuate the mandrel rod and/or sleeve. Of course, instead of the cammechanisms depicted in the Figures, direct linkage may be used toactuate the mandrel rod and/or sleeve.

Wound Site Management and Dilator

FIGS. 18-25A depict procedural embodiments of wound site managementduring and after a medical procedure, such as angioplasty. FIG. 18depicts a conventional tubular dilator 500 extending through the skin ofa patient. Typically, the dilator 500 is left in the skin following acompleted medical procedure. When the medical procedure has beencompleted, the wound site must be stabilized. Although the blood flowmay not be completely stopped, the blood flow is reduced to a pointwhere the coagulants in the blood can complete the wound closure. Tostart the stabilization process of the wound site, the doctor inserts aflexible guide wire 502 through an opening 504 in the end of the dilator500. FIG. 19 shows the step of removing the introducer 500 from thewound site after the guide wire 502 is properly inserted through theskin and into the vessel.

To facilitate efficient wound closure, another aspect of the presentinvention provides an introducer formed to center a closure deviceand/or elongate the wound site for more efficient and effective closure.FIG. 20 depicts the introducer 510 of the present invention, andcontinues the process from FIGS. 18 and 19 where the introducer 510slides over the guide wire 502 through an opening in the introducer 510and a portion of the introducer is placed into the vessel. Details ofthe introducer 510 are disclosed below.

FIG. 20 depicts the introducer 510 inserted over the guide wire 502(already in the artery) and inserted into the vessel. The introducerincludes a hollow elongated guide sheath 512 and dilator 520. Referringto FIG. 20A, the doctor urges the distal tip 516 of the dilator 520 intoand through the guide sheath 512 (over guide wire 502). A flexibledistal end 516 of the dilator 520 is inserted into the wound, until ablood marker BM indicates that the dilator 520 is properly positioned inthe artery. The blood marker BM located at a predetermined length alongthe dilator 520 allows blood to flow through a cavity 540 to alert thedoctor that the dilator 520, and more specifically the flexible distaltip 516, is properly inserted into a vessel. Most preferable, the distaltip 516 of the dilator includes a tapered portion 522 to facilitateeasier ingress into the artery. An additional blood marking passageway(not shown) can be included on the distal end of sheath 512 asprecautionary indicator of the depth of the sheath. Presence of blood inthis additional passageway is indicative of the sheath being pressed toofar and into the arterial wall or into the artery.

Preferably, the diameter of the distal end of the guide sheath 512 canexpand if outward pressure is applied from the inside surface of theguide sheath 512. More preferably, slits or weakened tear seams(described below) are formed in the distal end of the guide sheath 512to allow the diameter of the guide sheath to increase when pressure isapplied.

A feature of the guide sheath of the present invention is the use of twoor more wire guides to maintain the sheath centered on the wound site,to permit opposing sides of the wound to approximate, and to ensure thatthe closure device (e.g., stapler/staple, suturing device,cauterization, etc) remains centered about the wound so that woundclosure is centered. Preferably, wire guides are formed on opposingsides of the guide sheath 512. The wire guides are delivered into theartery by the dilator 520, as shown in FIGS. 21 and 26. The wire guides514 are preferably flexible, and removably coupled to the distal end 516of the dilator 520 and deployed into the wound, as shown in FIG. 26. Thewire guides can be held in openings or slots (not shown) on the sides ofthe dilator. Once the dilator is properly inserted into the wound to aproper depth (as indicated by the BM passageway), the dilator is removedfrom the wound and the guide sheath. To remove the dilator 520 from theguide sheath 512, the doctor first holds the guide sheath 512 andadvances the dilator 520 forward to release the wire guides, and thenbackward through the sheath to remove. This decouples the guide wires514A and 514B from the openings. After the guide rod has been inserted apredetermined distance, the doctor simply extracts the guide rod. Thisleaves the guide sheath 512 centered on the wound with the guide wires514A and 514B extending inside the wound.

As is understood to those skilled in the diagnostic and interventionalarts, a puncture in an artery or vein has a general tendency to manifesta circumferential slit or an elongated opening, since the cell structureforming this tissue forms circumferentially (rather than longitudinal)to support radial contraction of the vessel. The wire guides 514A and514B of the present enable the wound to approximate the natural state ofthe wound, i.e., elongated circumferentially. Preferably, the sheath hasa diameter approximately equal to the diameter of the opening or wound,and the wire guides 514A and 514B on the sides of the sheath approximatethe dimension of the long axis of the wound in its natural, elongatedstate, as best shown in FIG. 23. Approximation in this sense may meanthat the wire guides are less than or greater than (or equal to) thisdiameter. In effect, the wire guides in this position limit movement ofthe sheath along the long axis of the vessel, and since the wire guidesspan the elongated wound, movement along the short axis is likewiselimited. This ensures that any device inserted through the sheath isapproximately centered on the wound. Importantly, since the woundopening tends to assume the shape shown in FIG. 23 even in the absenceof the wire guides, the opposing tissue located along the short axistends to approximate. The present invention takes advantage of thistendency for positioning and alignment of a sheath. If the position ofthe wire guides define a diameter larger than the diameter of the wound,the tissue along the short axis tends to approximate more (i.e., thetissue is stretched along the long axis). However, sufficient wound sitemanagement does not require that the wire guides stretch the wound.Rather, if the position of the wire guides are shorter than the woundlength, the wire guides still serve to maintain the sheath generallycentered at the wound. In both circumstances, the wire guides ensurethat a staple deployment is centered, and that a significant amount oftissue is grasped by the staple for closure. Also, if the wound openingin the tissue is held taught by the introducer, there is less tendencyfor the tissue surrounding the opening to slip down into the vesselduring staple deployment (which would reduce the effectiveness of theclosure). FIG. 23 also shows examples of locations S1, S2, S3, and S4 ofwhere the prongs of the staple to be inserted will line-up relative tothe wound opening WO. The guide wires 514 are preferably disposed onopposing sides of the guide sheath 512, and more preferable, the guidewires are inserted into the wound opening transversally to the long axisof the artery or vein, so that the wound is pulled taught in atransverse direction.

FIG. 22 shows the distal end of a stapler 104 with a staple 10/50 beinginserted through the guide sheath 512 of the introducer 510. FIG. 22Adepicts a relief view of the introducer 510, and more clearly depictsthe slits or weakened tear seams 700. When the distal end of the stapler104 is properly inserted in the guide sheath 512, the staple can bedeployed into the tissue. FIG. 24 shows the first step of stapledeployment, the process of which is described in detail above. Note thatin FIG. 24A, the extension of the staple prongs causes the weakened tearseam or slits to separate. This further causes the wire guides to expandagainst the long axis of the wound, thereby further approximating thetissue surrounding the opening. FIGS. 25 and 25A depict the staple fullydeployed into tissue, the process of which is described above. Thestapler can now be removed from the guide sheath 512. The guide sheath512 can now be urged away from the wound opening WO and the guide wires514A and 514B are extracted from the closed opening.

Although the present invention has been described in relation toparticular embodiments thereof, many other variations and modificationsand other uses will become apparent to those skilled in the art. It ispreferred, therefore, that the present invention be limited not by thespecific disclosure herein, but only by the appended claims.

What is claimed is:
 1. A method for delivering a staple to seal anopening through tissue comprising: receiving a staple slidably disposedabout an outer surface of an elongate member, the elongate member havinga centerline axis and a substantially conically shaped distally flaredportion, and a sheath surrounding the staple and overlying at least aportion of the outer surface of the elongate member; inserting a distalend of the elongate member into the opening through tissue; advancingthe staple over the distally flared portion of the elongate member, thestep of advancing the staple causing at least three distally facingtissue-piercing prongs of the staple to move away from the centerlineaxis along respective radial lines extending from centerline axis tocause the sheath to diametrically expand; and deploying the staple fromthe elongate member within the opening such that the distally facingprongs pierce the tissue and move towards the centerline axis along therespective radial lines.
 2. The method of claim 1, further comprisingwithdrawing the elongate member from the opening.
 3. The method of claim1, wherein the sheath comprises a weakened region surrounding the distalend of the elongate member, the weakened region tearing as the staple isadvanced toward the distal end of the elongate member.
 4. The method ofclaim 1, wherein the opening through tissue extends through at leastskin tissue, and wherein the sheath facilitates advancement of thestaple along the opening.
 5. The method of claim 1, wherein the openingthrough tissue communicates with an artery or a vein, and wherein thedeploying step comprises substantially sealing the opening from bloodflow there through with the staple.
 6. The method of claim 1, whereinthe sheath comprises at least one longitudinal slit or tear seam, the atleast one slit or tear seam opening as the staple is advanced, therebypermitting the sheath to diametrically expand.
 7. The method of claim 1,further comprising, inserting at least one centering guide into theopening through tissue, the centering guide extending beyond a distalend of the sheath.